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Diphenoxylate-Atropine (Lomotil) Toxicity in Infantile Diarrhea: a Case Report of Therapeutic Failure

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Diphenoxylate-Atropine (Lomotil) Toxicity in Infantile Diarrhea: a Case Report of Therapeutic Failure Open Access Case Report DOI: 10.7759/cureus.5875 Diphenoxylate-atropine (Lomotil) Toxicity in Infantile Diarrhea: A Case Report of Therapeutic Failure Hamza R. Khan 1 , Sarrah Ali Asghar 2 , Sharfa Kanwal 1 , Laila Tul Qadar 2 , Kashif H. Qadri 3 1. Internal Medicine, Quaid-e-Azam Medical College, Bahawalpur, PAK 2. Internal Medicine, Dow University of Health Sciences, Karachi, PAK 3. Pediatrics, Dow University of Health Sciences, Karachi, PAK Corresponding author: Hamza R. Khan, [email protected] Abstract Diphenoxylate-atropine (Lomotil) intoxication incidence was significantly high in the past, but seeing such cases in the present day of modern and advanced medicine, hints about the gaps in the practice of medicine. In our case, a general physician maltreated an infant for diarrhea with an adult dose of diphenoxylate- atropine (Lomotil), a Food and Drug Administration (FDA) unapproved drug, which caused labored breathing and pinpoint pupils. After being maltreated, at the time of presentation to the emergency room (ER), she was being misdiagnosed as a case of dehydration until doctors noticed miosis and reached the diagnosis of diphenoxylate-atropine (Lomotil) toxicity. Her condition completely reversed with a single dose of naloxone. Hence, this case highlights the need for basic knowledge about the dosage of drugs for different age groups, especially infants, along with the importance of adherence to the evaluation protocols for accurate management. Categories: Internal Medicine, Pediatrics, Preventive Medicine Keywords: diphenoxylate-atropine toxicity, drug contraindications, diarrhea, dosage, naloxone, lomotil Introduction Diarrhea is a dangerous sign for the health of a child. Hence, it requires appropriate and timely management. The first-line approach for managing a case of diarrhea is physiological, which includes rehydration, either orally or through the intravenous route. The pharmacological method comprising antidiarrheals as adjuvant therapy is also used [1]. The most common antidiarrheals prescribed by general physicians in our country are diphenoxylate-atropine (Lomotil) and loperamide [2]. Lomotil is a synthetic substance that is chemically related to meperidine. A subtherapeutic dosage of atropine, an anticholinergic, is added to the preparation, to discourage deliberate overdose. It has the role of an antisecretory agent when it acts on enteric μ-opioid receptors, resulting in the release of noradrenaline as a final mediator. It also acts as a spasmogenic to prolong gastric emptying and decrease bowel frequency, Received 09/27/2019 Review began 10/06/2019 thus rendering the gut atonic [3-4]. The use of diphenoxylate-atropine (Lomotil) in higher than the Review ended 10/07/2019 prescribed dosage can cause toxicity. Clinical presentations in a case of toxicity vary in terms of which a Published 10/09/2019 component of the drug (opioid or anticholinergic) will dominate first. The metabolism of diphenoxylate © Copyright 2019 involves rapid and extensive conversion by ester hydrolysis into difenoxin, which is biologically five times Khan et al. This is an open access article more active and a major metabolite in the blood [5]. Antidiarrheal diphenoxylate-atropine (Lomotil) is distributed under the terms of the available in forms like tablets and syrup. The composition of a single pill of diphenoxylate-atropine Creative Commons Attribution License (Lomotil) is 2.5 mg of diphenoxylate and 0.025 mg of atropine sulfate. The dose of usually two tablets, which CC-BY 3.0., which permits unrestricted use, distribution, and reproduction in any is prescribed to adults only produces required opioid effects locally in the gut to control diarrhea. However, medium, provided the original author and the same treatment can cause central nervous system (CNS) and respiratory depression in an infant or child. source are credited. Despite well-documented risks and toxicities of this drug as well as contraindications of its use at an age of fewer than two years by the Food and Drug Administration (FDA) [6], doctors of our locality still prescribe it with no important instructions to parents. Herein, we present a case of diphenoxylate-atropine (Lomotil) toxicity in a 10-month-old infant treated for diarrhea. Case Presentation A 10-month-old female child presented in the emergency room (ER) of Dr. Ruth KM Pfau, Civil Hospital Karachi (CHK), with an altered level of consciousness and shallow breathing. The child was vaccinated according to the expanded program on immunization (EPI) but was malnourished, with an unsubstantial history of family illnesses. The patient was accompanied by her mother. She weighed 6.6 kg, is the fourth- born child to her parents and was delivered at term to a 37-year-old G4P4 (gravida 4 para 4) mother via normal vaginal delivery. The mother did not disclose any complications during pregnancy. The patient developed respiratory distress since that morning accompanied by low-grade intermittent fever on the day of presentation. She had a history of loose, watery diarrhea for one day. There were 12 episodes How to cite this article Khan H R, Ali Asghar S, Kanwal S, et al. (October 09, 2019) Diphenoxylate-atropine (Lomotil) Toxicity in Infantile Diarrhea: A Case Report of Therapeutic Failure. Cureus 11(10): e5875. DOI 10.7759/cureus.5875 of watery motions, not blood-stained, for which treatment was taken by the nearby general physician, including antibiotics, zinc supplements, and two tablets of diphenoxylate-atropine after which diarrhea was resolved. Past medical history revealed the child is developmentally delayed and is being treated for maculopapular rash. The mother also noticed weight loss and altered bowel habits, although micturition was normal. On examination, the patient was lying on the bed, irritated and lethargic, having labored breathing. Initial vitals included blood pressure (BP) 129/103 mmHg, a regular pulse of 201 beats/min, a respiratory rate of 15 breaths/min, and a low-grade fever of 99.7° F. The patient was anemic and dehydrated, with no visible signs of clubbing, cyanosis, edema, and lymphadenopathy. Various lab investigations were ordered, which include complete blood count (CBC) (Table 1), urea creatinine electrolytes (UCE) (Table 2), and arterial blood gas (ABG) (Table 3). All other systems were unremarkable. Parameters Result Normal Value Hemoglobin (g/dL) 12.3 11-16 Mean corpuscular volume (fl) 91.6 82-95 Mean corpuscular hemoglobin (pg) 32.2 27-31 Mean corpuscular hemoglobin concentration (g/dL) 35.1 32-36 Total leukocyte count (109/L) 10.7 4-11 Neutrophils (%) 32.7 40-70 Lymphocytes (%) 46.7 20-45 Platelets (103/μl) 370 150-450 TABLE 1: CBC of our patient CBC: Complete blood count Parameters Result Normal Value Blood urea nitrogen (mg/dL) 6 7-20 Creatinine (mmol/L) 0.3 0.6-0.12 Na (mmol/L) 137 135-145 K (mmol/L) 4.6 3.5-5.1 Cl (mmol/L) 103 98-107 TABLE 2: Values of UCE in our patient UCE: Urea creatinine electrolytes 2019 Khan et al. Cureus 11(10): e5875. DOI 10.7759/cureus.5875 2 of 4 Parameters Result Normal Value pH 7.35 7.35-7.45 pCO2 (mmHg) 48 35-45 - HCO3 (mmol/L) 20 22-26 TABLE 3: An ABG test values of our patient ABG: Arterial blood gas On chest auscultation, harsh vesicular breathing and equal air entry were heard; the breathing pattern was abnormal and shallow. The presumptive diagnosis of dehydration was made. However, when reflexes were found to be brisk, with a pinpoint pupil, the diagnosis of opioid (diphenoxylate-atropine) toxicity was made, which was completely reversed by a single naloxone dose of 0.6 mg. The child responded immediately after the administration of naloxone and the breathing pattern also improved. The pinpointed pupil got settled toward dilation and became reactive. The level of consciousness was also regained. Discussion Diphenoxylate-atropine (Lomotil) ranks seventh on the list of deadly drugs that cause severe intoxication in children with just a single dose [7]. Anticholinergic overdose symptoms, from the most to the least common, include tachycardia, restlessness/anxiety, flushing, urinary retention, and diminished reflexes, while overdose symptoms due to the diphenoxylate component of diphenoxylate-atropine (Lomotil), from the most to the least common, are drowsiness, vomiting, respiratory depression, coma, and abdominal pain/constipation [7]. Miosis, seizures, or paralytic ileus may also be seen. Our patient exhibited many symptoms; however, the only point of diagnosis was the presence of miosis whereas other reports show that ocular toxicity, ototoxicity, and cardiac conduction defects like arrhythmias can occur [8]. Our infant patient was also given a single adult dose of two tablets for the treatment of diarrhea, which was controlled at the time of presentation to the ER. Presenting complaints were delayed sensorium, altered level of consciousness, and other signs and symptoms (S/S) mentioned above. Initially, the doctor thought that the patient is a simple case of dehydration, so she was being managed for it until her pupils were found to be pinpoint, which, on further inquiry from the mother, shifted the diagnosis to diphenoxylate- atropine (Lomotil) toxicity. As per reports, there are usually two phases of diphenoxylate-atropine (Lomotil) intoxication [5]. The first phase, which attributed to the dominant effects of atropine, shows S/S such as flushing, high fever, and tachypnea followed by the second phase of opioid dominance due to diphenoxylate mainly comprises CNS and respiratory depression along with miosis. Although our patient
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